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Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT03907098
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaojia Wang(xj wang), Zhejiang Cancer Hospital

Brief Summary:
This research study is studying endostar in combination with chemotherapy as a possible treatment for HER-2 negative advanced breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Endostar Drug: Chemotherapy Phase 2

Detailed Description:

This is a multi-center phase II open label single-arm study to assess the safety and efficacy of endostar in combination with chemotherapy for patients with locoregionally recurrent or metastatic HER-2 negative breast cancer.

Endostar is an anti-angiogenesis drug. It is prepared by adding 9 amino acids to the N-terminal of the peptide chain on the basis of endostatin. Studies have shown that there may be a synergistic effect between endostar and chemotherapeutic agents.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Endostar in Combination With Chemotherapy in HER-2 Negative Advanced Breast Cancer
Actual Study Start Date : June 30, 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: endostar + chemotherapy

Endostar 15 mg per square of BSA, continuous intravenous infusion 24 hours a day, continuous administration for 7 days, every three weeks.

Chemotherapy regimens are selected by physicians based on regular clinical decision.

Drug: Endostar
an anti-angiogenesis drug
Other Name: Recombinant human endostatin

Drug: Chemotherapy
Physician's choice




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: up to approximately 100 months ]
    From enrollment to disease progression or death due to any cause


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: up to approximately 100 months ]
    From enrollment to death due to any cause

  2. Objective Response Rate (ORR) [ Time Frame: up to approximately 100 months ]
    Ratio of CR and PR in all subjects

  3. Clinical Benefit Rate (CBR) [ Time Frame: up to approximately 100 months ]
    Ratio of CR,PR and SD more than or equal to 24 weeks

  4. Adverse events (AEs) [ Time Frame: from enrollment to 30 days after the last dose administration ]
    Described in terms of CTC AE 4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • locoregionally Recurrent or metastatic breast cancer confirmed by histology.
  • HER-2 Negative Breast Cancer.
  • At least one measurable lesion according to RECIST 1.1..
  • Chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks.
  • 18-70 years old.
  • ECOG PS 0~1.
  • Participants must have normal organ and marrow function as defined below: ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN;ALT and AST≤3×ULN(ALT and AST≤5×ULN if liver metastasis);BUN and Cr≤1.5×ULN and CCr≥50 mL/min.
  • life expectancy is not less than 12 weeks.
  • Signed informed consent.

Exclusion Criteria:

  • Uncontrolled central nervous system metastasis.
  • Not recovered to 0-1 degree (CTC AE 4.0) from toxic reactions of previous treatments..
  • History of allergy to biological agents in the past.
  • Important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension.
  • Pregnant or lactating women..
  • The patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer.
  • The risk of uncontrolled infection, thrombosis and bleeding exists.
  • A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
  • Researchers consider it inappropriate to carry out the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907098


Contacts
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Contact: Xiaojia Wang, PhD 86 13906500190 wxiaojia0803@163.com
Contact: Yuan Huang, PhD 86 13588747179 hy415@163.com

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Yuan Huang    057188122072      
Sponsors and Collaborators
Zhejiang Cancer Hospital

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Responsible Party: Xiaojia Wang(xj wang), Director, Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03907098     History of Changes
Other Study ID Numbers: ZJCHBC008
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaojia Wang(xj wang), Zhejiang Cancer Hospital:
breast cancer
endostar

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endostar protein
Endostatins
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents